The Home Edit Hand Sanitizer-Unscented by LAB-CLEAN, INC

The Home Edit Hand Sanitizer-Unscented by

Drug Labeling and Warnings

The Home Edit Hand Sanitizer-Unscented by is a Otc medication manufactured, distributed, or labeled by LAB-CLEAN, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THE HOME EDIT HAND SANITIZER-UNSCENTED- benzalkonium chloride liquid 
LAB-CLEAN, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Use

For hand Sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only.

• When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water.
• Do not ingest.
• Stop use and ask a doctor if irritation or redness develops and conditions persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Spray a small amount of product into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry.

Inactive ingredients

Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid

Package Label - Principal Display Panel

THE HOME EDIT HAND SANITIZER-UNSCENTED 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73126-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73126-030-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
2	NDC: 73126-030-02	82 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
3	NDC: 73126-030-03	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
4	NDC: 73126-030-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
5	NDC: 73126-030-05	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
6	NDC: 73126-030-06	320 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
7	NDC: 73126-030-07	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020
8	NDC: 73126-030-08	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2020	04/20/2024

Labeler - LAB-CLEAN, INC (199822219)

Establishment
Name	Address	ID/FEI	Business Operations
LAB-CLEAN, INC		199822219	manufacture(73126-030)

Revised: 4/2022

Document Id: dd944506-1da0-402b-e053-2a95a90a3430

34390-5

Set id: 5f2981ed-1ca8-44e1-a229-eb8bb6c3ba29

Version: 3

Effective Time: 20220426